Tangible Hydra-PEG: A Promising Solution for Scleral Lens Wearers With Dry Eye

Dry eye (DE) is a common complaint of millions of people worldwide with a significant impact
on quality of life. For decades, this condition has presented a challenge to eye care
professionals as conventional therapies are often ineffective. Recently, scleral lenses have
demonstrated to be a promising therapeutic and vision rehabilitative option for dry eye
sufferers. Nonetheless, despite the benefits of scleral lenses for dry eye patients,
inadequate wettability of scleral lenses with subsequent diminished comfort and visual
clarity remains a concern for scleral lens wearers with dry eye.

Tangible Hydra-PEG (Tangible Science LLC, Menlo Park, CA, USA) is a novel coating technology
designed to improve lens wettability, deposit resistance, and tear film breakup time,
ultimately enhancing contact lens comfort. While studies have shown that Tangible Hydra-PEG
technology can improve contact lens discomfort (CLD) in soft contact lens and gas permeable
lens wearers, to our knowledge, no clinical research investigation has examined the benefits
of this new coating on scleral lens wear in dry eye sufferers. As such, the aim of this study
is to compare the CLD and DE symptoms of dry eye scleral lens wearers between Tangible
Hydra-PEG treated scleral lens wear and untreated scleral lens wear. CLD and DE signs will
also be assessed to corroborate our findings.

This will be the first randomized double masked cross-over study to examine CLD and DE
symptoms of Tangible Hydra-PEG treated scleral lens wear compared to untreated scleral lens
wear in the dry eye patient population. Tangible Hydra-PEG treated scleral lenses can
potentially minimize CLD and DE symptoms, ultimately improving outcomes for patients coping
with dry eye disease. This study will provide new information about this innovative
technology and help practitioners envisage rehabilitative options which will best optimize
the quality of life of this important patient population.

Inclusion Criteria:

- Reduced tear film break up time (TBUT), a sign of dry eye disease and contact lens
discomfort

- Scleral lens wearer (at least 8 hours per day for at least 5 days per week and have
had their habitual lenses no longer than 1 year). Scleral lenses wear will be defined
as 15.00 mm to 19.00 mm inclusive.

Exclusion Criteria:

- Disorders that affect sensitivity (herpetic disease, severe diabetes mellitus)

- Anatomic variations of the conjunctiva that can impair proper scleral lens fitting

- Pregnancy

- Best corrected Snellen visual acuity worse than 20/30 in either eye

- Ocular pathology other than dry eye (e.g. glaucoma, macular degeneration, keratoconus)
which may significantly impact visual function.